Full Press Release Details
Halozyme Therapeutics
HALOZYME REPORTS THIRD QUARTER 2015 FINANCIAL RESULTS
- Revenue of $20.8 million increased 42 percent from prior-year period -
- Royalty Revenue of $8.3 million increased nearly 200 percent from prior-year period -
- Company on track to close enrollment of PEGPH20 Phase 2 study in pancreatic cancer patients by year-end -
SAN DIEGO, November 9, 2015 -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the third quarter ended September 30, 2015. Revenue for the quarter of $20.8 million and a net loss of $24.5 million, or $0.19 per share, compared to revenue of $14.6 million and a net loss of $20.3 million, or $0.16 per share, for the third quarter of 2014. Financial results for the quarter were in line with company expectations and its annual financial guidance, which the company reiterated today.
"With more than 100 patients now enrolled in Stage 2 of our Phase 2 study in pancreatic cancer patients, we are on track to close enrollment by the end of the year and achieve a major milestone toward our goal of ultimately commercializing PEGPH20," said Dr. Helen Torley, president and CEO. "Strong progress was made towards our goal of evaluating the pan tumor potential of PEGH20 by dosing the first patient in our immuno-oncology clinical trial in combination with Merck's KEYTRUDA and by executing well on our broader clinical trial roadmap, including planning for initiation of our Phase 3 study in pancreatic cancer at the end of the first quarter of 2016.
"At the same time, our ENHANZE technology platform continued to deliver a growing royalty revenue stream from collaboration and licensing agreements with Roche and Baxalta, and we achieved important milestones toward potential future royalties with Pfizer, Janssen and AbbVie. Further progress was demonstrated by Pfizer and Janssen who initiated dosing in separate Phase 1 clinical trials with ENHANZE, while AbbVie announced plans to work with Halozyme on HUMIRA (adalimumab) with the goal to help reduce the number of induction injections and deliver additional performance benefits."
Third Quarter 2015 Highlights and Subsequent Events include:
Third Quarter 2015 Financial Highlights
For the full year 2015, the company maintains its previously announced guidance of:
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, November 9, 2015 at 4:30 p.m. ET/1:30 p.m. PT. During the call, management will discuss financial results and provide a business update. To listen to the live webcast and view additional documents related to the call, please visit the "Investors" section of Halozyme's corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate by phone, please dial (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay passcode 75162222.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen and AbbVie for its drug delivery platform, ENHANZE , which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company's future expectations and plans for growth in 2015, the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected financial outlook for 2015) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected fluctuations or changes in revenues from collaborators, unexpected results or delays in development of product candidates and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015.
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 10,301 | $ | 9,617 | $ | 32,503 | $ | 27,679 | ||||||||
| Royalties | 8,274 | 2,895 | 21,431 | 5,382 | ||||||||||||
| Revenues under collaborative agreements | 2,205 | 2,094 | 28,896 | 11,896 | ||||||||||||
| Total revenues | 20,780 | 14,606 | 82,830 | 44,957 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 6,180 | 5,141 | 20,818 | 16,585 | ||||||||||||
| Research and development | 27,611 | 19,904 | 65,490 | 59,968 | ||||||||||||
| Selling, general and administrative | 10,226 | 8,587 | 29,439 | 27,589 | ||||||||||||
| Total operating expenses | 44,017 | 33,632 | 115,747 | 104,142 | ||||||||||||
| Operating loss | (23,237 | ) | (19,026 | ) | (32,917 | ) | (59,185 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 78 | 122 | 267 | 287 | ||||||||||||
| Interest expense | (1,301 | ) | (1,376 | ) | (3,899 | ) | (4,203 | ) | ||||||||
| Net loss | $ | (24,460 | ) | $ | (20,280 | ) | $ | (36,549 | ) | $ | (63,101 | ) | ||||
| Basic and diluted net loss per share | $ | (0.19 | ) | $ | (0.16 | ) | $ | (0.29 | ) | $ | (0.52 | ) | ||||
| Shares used in computing basic and diluted net loss per share: | 126,921 | 124,041 | 126,127 | 122,157 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| September 30, 2015 | December 31, 2014 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 71,514 | $ | 61,389 | ||||
| Marketable securities, available-for-sale | 52,204 | 74,234 | ||||||
| Accounts receivable, net | 8,392 | 9,149 | ||||||
| Inventories | 11,101 | 6,406 | ||||||
| Prepaid expenses and other assets | 9,879 | 10,143 | ||||||
| Total current assets | 153,090 | 161,321 | ||||||
| Property and equipment, net | 2,686 | 2,951 | ||||||
| Prepaid expenses and other assets | 2,458 | 1,205 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 158,734 | $ | 165,977 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,437 | $ | 3,003 | ||||
| Accrued expenses | 18,926 | 13,961 | ||||||
| Deferred revenue, current portion | 5,789 | 7,367 | ||||||
| Current portion of long-term debt, net | 15,699 | - | ||||||
| Total current liabilities | 44,851 | 24,331 | ||||||
| Deferred revenue, net of current portion | 44,244 | 47,267 | ||||||
| Long-term debt, net | 34,094 | 49,860 | ||||||
| Other long-term liabilities | 3,746 | 3,167 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 128 | 126 | ||||||
| Additional paid-in capital | 518,647 | 491,694 | ||||||
| Accumulated other comprehensive loss | - | (41 | ) | |||||
| Accumulated deficit | (486,976 | ) | (450,427 | ) | ||||
| Total stockholders' equity | 31,799 | 41,352 | ||||||
| Total liabilities and stockholders' equity | $ | 158,734 | $ | 165,977 |